Various Cancer Types

EAY191-E4



Testing the Use of Nilotinib and Paclitaxel as a Treatment for Patients with Prior Taxane Treatment, A ComboMATCH Treatment Trial

STATUS: Temporarily Closed to Accrual


This phase II ComboMATCH treatment trial evaluates nilotinib with paclitaxel for the treatment of patients with solid cancers that are growing, spreading, or getting worse (progressive) and that have previously been treated with taxane therapies. Nilotinib is in a class of medications called kinase inhibitors. It works by binding to and blocking the action of a protein called ABL, which signals tumor cells to multiply. This helps slow or stop the proliferation of tumor cells. Paclitaxel is a drug that blocks cell growth by stopping cell division and it may kill tumor cells. Giving nilotinib with paclitaxel may be effective at treating patients with progressive solid cancers that have previously been treated with taxane therapies.
  • Patient must be enrolled on the ComboMATCH registration protocol (EAY191) at the time of registration to the EAY191-E4 study

  • Patient must be >= 18 years of age

  • Patient must not have any of the following mutations (as determined by the ComboMATCH registration protocol), which are known to confer sensitivity or resistance to nilotinib monotherapy: * KIT: W557R, V559D, V559A, L576P, and K642E * PDGFR-alpha: D842V

  • Patient must have disease that can be safely biopsied and agree to a pre-treatment biopsy or have archival tissue available from within 12 months prior to the date of registration on the ComboMATCH registration trial (EAY191) * NOTE: The current actionable mutation of interest (aMOI)/actionable alteration list for this treatment trial can be found on the Cancer Trials Support Unit (CTSU) website * NOTE: Novel/dynamic aMOI can be submitted for review per the process described in the ComboMATCH registration protocol

  • Patient must be willing to provide blood samples for research purposes

  • Patient must have had at least one prior line of therapy in the metastatic setting

  • Patient must have previously undergone taxane therapy (in the metastatic setting) * Patients who previously responded to prior taxane therapy must have received their last dose of taxane therapy within 6 months prior to EAY191-E4 registration and have had no other intervening treatment prior to EAY191-E4 registration * Patients who did not respond to prior taxane therapy are eligible regardless of the time elapsed since the prior taxane therapy or any other intervening therapies

  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

  • Patient must not have had platinum-resistant epithelial serous ovarian cancer

  • Patients must not have neuropathy >= grade 2 within 14 days of registration/randomization

  • Patient must have documented QT interval with Fridericiaโ€™s correction (QTcF) of =< 450 msec within 8 days prior to EAY191-E4 registration. Patients with a QTcF interval of >= 450 msec at registration or patients with congenital long QT syndrome are not eligible

  • Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used * All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

  • Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for at least 3 months after the last dose of study drug

  • Patients must have progressive disease

  • Absolute neutrophil count (ANC) >= 1,500/mcL

  • Platelets >= 100,000/mcL

  • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (with the exception of those with Gilbert syndrome, who must have total bilirubin =< 3 x institutional ULN)

  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 institutional upper limit of normal; < 5.0 x ULN in patients with liver metastases

  • Creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine levels > 1.5 mg/dL

  • Patient must have the ability to swallow medications

  • Patient must have completed any prior therapy โ‰ฅ 4 weeks or โ‰ฅ 5 half-lives of the prior agent (whichever is shorter) prior to enrollment on protocol. Prior definitive radiation should have been completed โ‰ฅ 4 weeks prior to enrollment; prior palliative radiation should have been completed โ‰ฅ 2 weeks prior to enrollment. Patients must be โ‰ฅ 2 weeks since any investigational agent administered as part of a phase 0 study (where a sub-therapeutic dose of drug is administered) and should have recovered to grade 1 or baseline from any toxicities

  • Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for โ‰ฅ 1 month after treatment of the brain metastases

United States
AL
Birmingham
University of Alabama at Birmingham Cancer Center
Contact: Site Public Contact
Email: tmyrick@uab.edu

AZ
Kingman
Kingman Regional Medical Center
Contact: Site Public Contact
Email: research@sncrf.org

CA
Palo Alto
Stanford Cancer Institute Palo Alto
Contact: Site Public Contact
Email: ccto-office@stanford.edu

Whittier
Presbyterian Intercommunity Hospital
Contact: Site Public Contact

CO
Aurora
UCHealth University of Colorado Hospital
Contact: Site Public Contact

FL
Aventura
UM Sylvester Comprehensive Cancer Center at Aventura
Contact: Site Public Contact

Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
Contact: Site Public Contact

Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Contact: Site Public Contact

Miami
UM Sylvester Comprehensive Cancer Center at Kendall
Contact: Site Public Contact

University of Miami Miller School of Medicine-Sylvester Cancer Center
Contact: Site Public Contact

Plantation
UM Sylvester Comprehensive Cancer Center at Plantation
Contact: Site Public Contact

IA
Des Moines
Medical Oncology and Hematology Associates-Des Moines
Contact: Site Public Contact

ID
Boise
Saint Alphonsus Cancer Care Center-Boise
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Coeur D'Alene
Kootenai Health - Coeur d'Alene
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Nampa
Saint Alphonsus Cancer Care Center-Nampa
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Post Falls
Kootenai Clinic Cancer Services - Post Falls
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Sandpoint
Kootenai Cancer Clinic
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

IL
Barrington
Advocate Good Shepherd Hospital
Contact: Site Public Contact

Bloomington
Illinois CancerCare-Bloomington
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Canton
Illinois CancerCare-Canton
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Carthage
Illinois CancerCare-Carthage
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Centralia
Centralia Oncology Clinic
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Chicago
Advocate Illinois Masonic Medical Center
Contact: Site Public Contact

John H Stroger Jr Hospital of Cook County
Contact: Site Public Contact

Northwestern University
Contact: Site Public Contact
Email: cancer@northwestern.edu

Crystal Lake
AMG Crystal Lake - Oncology
Contact: Site Public Contact
Email: advocateresearch@advocate.com

Danville
Carle at The Riverfront
Contact: Site Public Contact
Email: Research@Carle.com

Decatur
Cancer Care Specialists of Illinois - Decatur
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Dixon
Illinois CancerCare-Dixon
Contact: Site Public Contact

Downers Grove
Advocate Good Samaritan Hospital
Contact: Site Public Contact
Email: Barbara.barhamand@advocatehealth.com

Effingham
Carle Physician Group-Effingham
Contact: Site Public Contact
Email: Research@carle.com

Crossroads Cancer Center
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Elgin
Advocate Sherman Hospital
Contact: Site Public Contact

Eureka
Illinois CancerCare-Eureka
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Galesburg
Illinois CancerCare-Galesburg
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Hazel Crest
Advocate South Suburban Hospital
Contact: Site Public Contact

Kewanee
Illinois CancerCare-Kewanee Clinic
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Libertyville
AMG Libertyville - Oncology
Contact: Site Public Contact
Email: advocateresearch@advocatehealth.com

Condell Memorial Hospital
Contact: Site Public Contact
Email: advocateresearch@advocatehealth.com

Macomb
Illinois CancerCare-Macomb
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Mattoon
Carle Physician Group-Mattoon/Charleston
Contact: Site Public Contact
Email: Research@carle.com

O'Fallon
Cancer Care Center of O'Fallon
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Oak Lawn
Advocate Christ Medical Center
Contact: Site Public Contact

Ottawa
Illinois CancerCare-Ottawa Clinic
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Park Ridge
Advocate Lutheran General Hospital
Contact: Site Public Contact

Pekin
Illinois CancerCare-Pekin
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peoria
Illinois CancerCare-Peoria
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peru
Illinois CancerCare-Peru
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Princeton
Illinois CancerCare-Princeton
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Springfield
Memorial Medical Center
Contact: Site Public Contact
Email: pallante.beth@mhsil.com

Southern Illinois University School of Medicine
Contact: Site Public Contact

Springfield Clinic
Contact: Site Public Contact

Urbana
Carle Cancer Center
Contact: Site Public Contact
Email: Research@carle.com

Washington
Illinois CancerCare - Washington
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

KY
Lexington
University of Kentucky/Markey Cancer Center
Contact: Site Public Contact

LA
New Orleans
Ochsner Medical Center Jefferson
Contact: Site Public Contact
Email: Elisemarie.curry@ochsner.org

MD
Bethesda
National Institutes of Health Clinical Center
Contact: Site Public Contact

ME
Brewer
Lafayette Family Cancer Center-EMMC
Contact: Site Public Contact

MI
Ann Arbor
Saint Joseph Mercy Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Brighton
Saint Joseph Mercy Brighton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Brighton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Canton
Saint Joseph Mercy Canton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Canton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Chelsea
Saint Joseph Mercy Chelsea
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Flint
Genesee Cancer and Blood Disease Treatment Center
Contact: Site Public Contact
Email: wstrong@ghci.org

Genesee Hematology Oncology PC
Contact: Site Public Contact
Email: wstrong@ghci.org

Genesys Hurley Cancer Institute
Contact: Site Public Contact
Email: wstrong@ghci.org

Hurley Medical Center
Contact: Site Public Contact
Email: wstrong@ghci.org

Lansing
Sparrow Hospital
Contact: Site Public Contact

Livonia
Trinity Health Saint Mary Mercy Livonia Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Macomb Township
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Contact: Site Public Contact
Email: karen.forman@ascension.org

Ypsilanti
Huron Gastroenterology PC
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

MN
Bemidji
Sanford Joe Lueken Cancer Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

MO
Cape Girardeau
Saint Francis Medical Center
Contact: Site Public Contact
Email: sfmc@sfmc.net

Farmington
Parkland Health Center - Farmington
Contact: Site Public Contact

Saint Louis
Missouri Baptist Medical Center
Contact: Site Public Contact

Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Contact: Site Public Contact

Sullivan
Missouri Baptist Sullivan Hospital
Contact: Site Public Contact

Sunset Hills
BJC Outpatient Center at Sunset Hills
Contact: Site Public Contact

MT
Anaconda
Community Hospital of Anaconda
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Billings
Billings Clinic Cancer Center
Contact: Site Public Contact
Email: research@billingsclinic.org

Bozeman
Bozeman Deaconess Hospital
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Great Falls
Benefis Healthcare- Sletten Cancer Institute
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Kalispell
Kalispell Regional Medical Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Missoula
Community Medical Hospital
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

ND
Bismarck
Sanford Bismarck Medical Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Fargo
Sanford Broadway Medical Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Roger Maris Cancer Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

NV
Henderson
OptumCare Cancer Care at Seven Hills
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas
OptumCare Cancer Care at Charleston
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at Fort Apache
Contact: Site Public Contact
Email: research@sncrf.org

NY
Buffalo
Roswell Park Cancer Institute
Contact: Site Public Contact
Email: askroswell@roswellpark.org

New York
Mount Sinai Hospital
Contact: Site Public Contact
Email: CCTO@mssm.edu

OH
Dayton
Dayton Physician LLC-Miami Valley Hospital North
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Kettering
Kettering Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Toledo
Toledo Clinic Cancer Centers-Toledo
Contact: Site Public Contact

OK
Oklahoma City
University of Oklahoma Health Sciences Center
Contact: Site Public Contact
Email: ou-clinical-trials@ouhsc.edu

OR
Ontario
Saint Alphonsus Medical Center-Ontario
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Portland
Providence Portland Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

SD
Sioux Falls
Sanford Cancer Center Oncology Clinic
Contact: Site Public Contact
Email: OncologyClinicTrialsSF@sanfordhealth.org

Sanford USD Medical Center - Sioux Falls
Contact: Site Public Contact
Email: OncologyClinicalTrialsSF@SanfordHealth.org

TX
Houston
M D Anderson Cancer Center
Contact: Site Public Contact
Email: askmdanderson@mdanderson.org

WI
Appleton
ThedaCare Regional Cancer Center
Contact: Site Public Contact
Email: ResearchDept@thedacare.org

Grafton
Aurora Cancer Care-Grafton
Contact: Site Public Contact
Email: ncorp@aurora.org

Green Bay
Aurora BayCare Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org

La Crosse
Gundersen Lutheran Medical Center
Contact: Site Public Contact
Email: cancerctr@gundersenhealth.org

Madison
University of Wisconsin Carbone Cancer Center
Contact: Site Public Contact

Marinette
Aurora Bay Area Medical Group-Marinette
Contact: Site Public Contact
Email: ncorp@aurora.org

Milwaukee
Aurora Saint Luke's Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org

Aurora Sinai Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org

Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Contact: Site Public Contact
Email: ncorp@aurora.org

Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Contact: Site Public Contact
Email: ncorp@aurora.org

Summit
Aurora Medical Center in Summit
Contact: Site Public Contact
Email: ncorp@aurora.org

Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Contact: Site Public Contact
Email: ncorp@aurora.org

Wauwatosa
Aurora Cancer Care-Milwaukee West
Contact: Site Public Contact
Email: ncorp@aurora.org

West Allis
Aurora West Allis Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org

PRIMARY OBJECTIVE:
I. To evaluate the proportion of patients with taxane-refractory advanced malignancies who have objective responses (OR) to treatment with nilotinib hydrochloride monohydrate (nilotinib) and paclitaxel.

SECONDARY OBJECTIVE:
I. Collect tissue and provide it to the ComboMATCH registration protocol to assess concordance between the diagnostic tumor mutation profile generated by the designated laboratories, the pre-treatment biopsy mutation profile, and the pre-treatment circulating tumor deoxyribonucleic acid (ctDNA) mutation profile from plasma, as described in ComboMATCH registration protocol. For this treatment substudy, the outcome objective will be to report the proportion of cases providing sufficient tissue for that integrated scientific activity in the ComboMATCH registration protocol.

EXPLORATORY OBJECTIVES:
I. To evaluate progression free survival (PFS) at 6 months on study agents.
II. To identify genomic and transcriptomic determinants of response and resistance in tumor biopsy specimens and cell-free deoxyribonucleic acid (DNA).

OUTLINE:
Patients receive nilotinib hydrochloride monohydrate orally (PO) twice daily (BID) on days 1-28 and paclitaxel intravenously (IV) over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) or magnetic resonance imaging (MRI) throughout the study. Patients also undergo collection of blood samples and tumor biopsy on study.

After completion of study treatment, patients are followed until disease progression, and for survival for 3 years from registration.

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network. This trial is part of the ComboMATCH precision medicine intiative.


EAY191-E4 / ComboMATCH-E4 Home Page
ECOG-ACRIN Cancer Research Group